I was the president of Pfizer Global Research and Development in 2007 where I managed more than 13,000 scientists and professionals in the United States, Europe, and Asia. I've received numerous awards including an Honorary Doctor of Science degree from the University of New Hampshire. I am also the author of "Drug Truths: Dispelling The Myths Of R&D" and the recently published Devalued And Detrusted: Can The Pharmaceutical Industry Restore Its Broken Image?" I am also a senior partner at PureTech Ventures.

Bad Pharma? Maybe. But Goldacre's Selective Use of Data Is Wrong

Ben Goldacre is now on a North American tour promoting his book, Bad Pharma, his expose of the pharmaceutical industry. On the book’s overleaf, he has the following quote:

“The tricks and distortions documented in these pages are beautiful, intricate, and fascinating in their details.”

Actually, the same can be said for examples that Goldacre uses to make various points in his book. Goldacre has major concerns about the need for more transparency when it comes to making data from clinical trials publicly available. In fact, he spends about one-third of Bad Pharma discussing this topic. I agree that one of the big challenges that the industry faces is the need to be more transparent about its work and I have written about this both on this blog and in Devalued & Distrusted. However, Goldacre’s cherry-picking of data to fit his arguments is inappropriate and infuriating to those who know something about the pharmaceutical industry.

Right at the outset of Bad Pharma, Goldacre tells the story of TGN1412. This is a horrific tale of six young males who, in 2006, volunteered for a phase 1 study for a novel drug, TGN1412. Phase 1 is the very first step in the study of a new drug in people. It is simply meant to test the drug, initially at very low doses, to see how well tolerated it is. TNG1412 was an antibody designed to stimulate the immune system and, in doing so, fight cancer in a whole new way. The hope for TGN1412 was to have it used to treat a rare form of leukemia.

Unfortunately, the volunteers in this phase 1 trial suffered immediate and severe side-effects. These men experienced an immunological firestorm in that the antibody caused the uncontrolled release of toxins. As a result, the volunteers suffered severe adverse events starting with rapid blood pressure lowering, then respiratory issues, kidney failure, etc. Fortunately, thanks to extraordinary efforts by excellent doctors in London Hospitals, all survived.

Goldacre’s purpose in telling this story is that he feels this episode could have been prevented in two ways. First, since this is an unprecedented experimental treatment, the drug should have not been given to six volunteers simultaneously, but rather in a staggered process. He is correct on this. Had this been done, only one volunteer would have been endangered. But his second concern is a real stretch. He believes that a study done ten years earlier by an academic researcher on a single subject could have foretold the events with TGN1412. Unfortunately, this result was never published. Goldacre uses this example to support his argument that pharma selectively publishes data and, in doing so, harms patients.

Here is what Goldacre does NOT tell you about TGN1412.

1) TGN1412 was being developed, not by a pharma company, but by TeGenero, a biotech company with 15 employees that was formed based on work done at the University of Wurzburg. TeGenero, a 15 person company, was not exactly a big pharma.

2) This was known to be a controversial area of research as people were worried that toying with the immune system could have dire consequences. Thus, experts in the field urged caution. The risks were well understood without the need of knowing about a single experiment 10 years earlier. My guess is that some experts would not agree that this isolated incident was truly relevant to the TNG1412 case.

“It is certainly possible to change the way in which novel agents are tested to minimize the number of subjects who are put at risk. As long as we continue to manipulate biology in new ways, we probably cannot prevent all such events from occurring. We must do what we can to minimize risk, but the future health of the world population demands that we not let adverse events put an end to medical progress. We must treat those at risk with respect and great care, but the work must go on.” Dr. Jeffrey M. Drazen

Given this additional background, it is hard to see why Goldacre uses this example to support his arguments. Perhaps it to use sentences like: “Their fingers and toes went flushed, then brown, then black, and then began to rot and die.” That should certainly raise the ire of the general public. Unfortunately, this case is being used for sensationalism and not to advance the cause that Bad Pharma claims to espouse.

Post Your Comment

Post Your Reply

Forbes writers have the ability to call out member comments they find particularly interesting. Called-out comments are highlighted across the Forbes network. You'll be notified if your comment is called out.

Comments

You say you try to make more profit in order to spend more on innovation. Drug companies often say this. Dr. Goldacre responds by pointing out that they spend much more on marketing and promotion than on R&D. As all you want is to help patients, why not close down your marketing department and channel the savings into research (real research, not me-too stuff!)? After all, all marketing does is try to shift doctors’ decisions away from evidence-based judgment in favor of the particular company’s products.

Seriously? The point from a medical and scientific point of view and from the view of patients is NOT about $elling drugs. That’s precisely the problem. Fostering a capitalist model has destroyed innovation and rendered the practice of medicine a sleazy business that too often has little to do with patient outcomes and more to do with stock portfolios and bloated executive income. As but one result, multi-drug resistant infectious diseases are proliferating and therapeutic options declining. We HAVE a system of discovery, in fact a couple, that is superior to the paranoid, secretive and opaque one of pharma. There is one in the public sector (e.g., NIH) and another in universities and hospitals; other open-source efforts are developing as we speak. Collectively, these are efforts I hope will see the end of companies like Pfizer which are moribund nightmares of genocidal greed. Let’s add what your company did in re Fluconazole in Africa to the litany of suffering and death your desperation to sell arbitrarily, capriciously and horrifically overpriced drugs has caused.

(In an interesting Freudian slip, you elided “without some [MONEY] for marketing” underscoring a sense of guilt? Well, ask your psychiatrist who no doubt has quite a few drugs to give you that are poorly tested and lied about through selective pharma reporting).

But what about the unpublished trial data for all the medications, from antidepressants to heart drugs, that we are currently using? Isn’t the “Selective” Publishing of Clinical Trial Data the real problem?

Given your experience at Pfizer, what do you think about the published and unpublished trial data for Reboxetine?

Here what BMJ says:

“Comparison of the published data with the full dataset (published and unpublished) showed that the published data overestimated the beneficial effect of reboxetine compared with placebo by 99-115% and of reboxetine compared with SSRIs by 19-23%.” BMJ, 13 October 2010

Selective publishing is wrong. I believe that that the changes being made in logging ALL trials onto ClinicalTrials.gov and then following up with the results will finally end this problem. This doesn’t fix the problems of the past in not having all the data available from before 2000, but it’s a good way forward.

We put medical trials through all kinds of rigor to ensure that it’s all done ‘scientifically” without bias. After all this, it seems incredibly stupid to allow researchers to pick and choose which trials they publish.

You suggest that “logging ALL trials onto ClinicalTrials.gov… will finally end this problem.” However “ALL” (i.e., 100%) trials are NOT being registered. In a cross section study published in BMJ, compliance, as defined by FDAAA rules, was only 22%.

Almost 4 out of 5 trials are NOT being registered. With 78% opting out, ClinicalTrials.gov clearly does not have the power to force compliance. And it obviously does not have the data to solve this problem.

ClinicalTrials.gov is toothless and useless.

Every day Doctors make life-changing and life-saving decisions based on the published information we have on prescription medicines. But this information is distorted by selective publishing, which leads to bad decisions. People are being hurt.

All trials are being logged onto ClinicalTrials.gov. It’s the reporting the results of the trials that is lagging. The BMJ number of 22% is correct, but you leave out two points: 1) the BMJ believes that 10% of the trials don’t fall under the category of needing to be reported; 2) the BMJ also reported that only 46% of trials run by academics have reported their results on ClinicalTrials.gov. In “Devalued & Distrusted” I put ALL these facts in, not just the ones selected by Dr. Goldacre. I also say that the industry needs to do a way better job in this area if it is to “restore its broken image”.

Since Dr. Goldacre has clearly stated the same thing about this not being limited to the pharmaceutical industry, why do you selectively pick out his accurate criticism of the pharmaceutical industry for defense?

Dr. Goldacre has been fair in his criticism of drug companies, alternative medicine, and others who abuse science.

You choose to cherry-pick his completely valid, and well documented, criticism of drug companies as being unfair to this poor little industry.

Dr. Goldacre makes it clear that most of the problems with research are not due to fraud, or intentional deception, but rather due to bias.

You ignore these repeated statements. You seem to be exhibiting your own bias and ignoring what Dr. Goldacre actually wrote.